Summary of Clinical Use

Used to treat CD33-positive acute myeloid leukemia (AML) in patients over 60 who are not candidates for other chemotherapy. Note that as requested by the US FDA, the drug was withdrawn from the US market in 2010, due to questions over its effectiveness and safety. Other international regulatory authorities still approved use of this drug. In September 2017, after careful reveiw, the FDA approved gemtuzumab ozogamicin for two new uses: 1. Initial use in adults whose AML tumours express the CD33 antigen. 2. For patients aged ≥2 years with relapsed or refractory CD33-positive AML. In June 2020 FDA approval was expanded to include pediatric patients ≥1 month old, with newly-diagnosed CD33-positive AML

Mechanism Of Action and Pharmacodynamic Effects

Antineoplastic conjugate of anti-CD33 antibody and the cytotoxic antibacterial calicheamicin γ1. The conjugate binds to the cell surface receptor and is rapidly internalised, subsequently the calicheamicin γ1 binds to the minor groove of DNA molecules and causes DNA double-strand breaks which triggers apoptosis.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT00372593	Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia	Phase 3 Interventional	Children's Oncology Group		2

External links

For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA)